A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants

Recruiting now

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.

Key facts

Study ID

NCT07532863

Run by

Novo Nordisk A/S

People needed

400

Starts

2026-03-13

Expected to finish

2027-03-27

Last updated by the study team

2026-07-28

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged greater than equal to (≥) 40 and less than (<) 70 years
• Male or female
• Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023

You may not qualify if…

• If any exclusion criterion is met, the participant will be excluded from the study.
• T1DM or gestational diabetes
• Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM
• Pregnant women
• With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease
• Died within 12 months after first diagnosis of T2DM
• Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM

Where it is running

• Novo Nordisk Investigational Site — Singapore, Singapore (enrolling)
• Siloam Hospitals Lippo Village — Tangerang, Banten, Indonesia
• Siloam Hospitals Surabaya — Surabaya, East Java, Indonesia
• University Malaya Medical Centre — Lembah Pantai, Kuala Lumpur, Malaysia
• National Heart Institute — Kuala Lumpur, Malaysia
• The Medical City Ortigas — Pasig, National Capital Region, Philippines

Full record on ClinicalTrials.gov

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